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临床试验/NCT02860247
NCT02860247已完成不适用

Rapid Detection of Bacterial Resistance by MALDI-TOF MS and Antibiotic Savings

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 103 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
主要终点
Comparison of antibiotic resistance

研究概览

简要总结

This study aims at determining within a short time (<3h) the susceptibility to clinical isolates of E. coli to the major antibiotics directly from positive blood cultures.

详细描述

The resistance to antibiotic is a concern for the great majority of pathogenic bacteria. The proportion of antibiotic-resistant bacteria is particularly high in hospital settings. The accumulation of resistance mechanisms can lead to multidrug resistance, therapeutic impasses and a subsequent higher mortality of infected patients. The use of antibiotics in humans and animals creates a selection pressure that favors the dissemination of antibiotic resistant strains. It's necessary to optimize antibiotic consumption to limit the spread of these bacteria. It requires both the fast bacterial identification and the fast determination of their resistance profile in order to use narrower-spectrum compounds.

Usually antibiotic susceptibility testing usually takes 18-24 hours. Mass Spectrometry type Matrix-Assisted Laser Desorption Ionization Time-Of-Flight (MALDI-TOF MS) has become a valuable tool in clinical laboratories for pathogen identification. Preliminary data showed that susceptible and resistant bacteria can be differentiated within 1 or 2 hours with a new technology called 'MS-ASTRA' based on a lower global peak intensity in the presence of the antibiotic of interest (at a concentration corresponding to the susceptibility breakpoint defined by the EUCAST) than in its absence. The objective of this study is to evaluate the performances of this new MALDI-TOF MS method on a panel of wild-type and resistant clinical isolates.

This study aims to determine the resistance of Escherichia coli isolates to cefotaxime, piperacillin-tazobactam, amoxicillin and to implement the method to positive blood cultures. Minimal Inhibitory Concentrations will be determined the standard agar dilution method.

Results and full analyze are deliverable within 2 years. The data obtained with the MS-ASTRA technique will be compared with the resistance status of the clinical isolates. The shortest incubation time (1 or 2 hours) that gives the more accurate result will be evaluate.The antibiotic savings that the implementation of this new method could have allowed will be evaluate.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients hospitalized in the hospital of Besançon, with a sepsis with E. coli.

排除标准

  • Patients without sepsis with E. coli

结局指标

主要结局

Comparison of antibiotic resistance

时间窗: Immediate

assessed by MALDI-TOF MS with that of the reference method (E-test)

次要结局

  • Antibiotic savings that could have occurred if the MALDI-TOF MS method was implemented(Immediate)

研究者

申办方类型
Other
责任方
Sponsor

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